ID

41790

Description

The objective is to assess the relieving effect of Caphosol® oral rinse on clinical outcomes which include oral intake, swallowing function and pain associated with incidence of grade ≥ 1 oral side effects and the anticancer therapy cessation in patients treated with selected targeted anticancer therapy.

Keywords

Versions (2)
  1. 1/20/21 1/20/21 - Ahmed Rafee, MD
  2. 1/21/21 1/21/21 - Ahmed Rafee, MD
Copyright Holder

Impaqtt Foundation

Uploaded on

January 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Oral Mucositis NCT01265810

English

Eligibility Oral Mucositis NCT01265810

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
≥18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
histological proof of rcc, hcc or gist
Description

Histological diagnosis of RCC | Histologicaldiagnosis of HCC | Histological diagnosis of GIST

Data type

boolean

Alias
UMLS CUI [1,1]
C0679557
UMLS CUI [1,2]
C0007134
UMLS CUI [2,1]
C0679557
UMLS CUI [2,2]
C2239176
UMLS CUI [3,1]
C0679557
UMLS CUI [3,2]
C0238198
oral adverse events > grade 0 due to sunitinib, sorafenib, pazopanib, temsirolimus, or everolimus in mono therapy at study entry
Description

Oral adverse events due to mono therapy with sunitinib, sorafenib, pazopanib, temsirolimus, or everolimus at study entry

Data type

boolean

Alias
UMLS CUI [1,1]
C1176020
UMLS CUI [1,2]
C4763675
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C0442027
UMLS CUI [2,1]
C1516119
UMLS CUI [2,2]
C4763675
UMLS CUI [2,3]
C0877248
UMLS CUI [2,4]
C0442027
UMLS CUI [2,5]
C2697888
UMLS CUI [3,1]
C1831796
UMLS CUI [3,2]
C4763675
UMLS CUI [3,3]
C0877248
UMLS CUI [3,4]
C0442027
UMLS CUI [3,5]
C2697888
UMLS CUI [4,1]
C1707080
UMLS CUI [4,2]
C4763675
UMLS CUI [4,3]
C0877248
UMLS CUI [4,4]
C0442027
UMLS CUI [4,5]
C2697888
UMLS CUI [5,1]
C0541315
UMLS CUI [5,2]
C4763675
UMLS CUI [5,3]
C0877248
UMLS CUI [5,4]
C0442027
UMLS CUI [5,5]
C2697888
written informed consent
Description

Written Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
eastern co-operative oncology group (ecog) performance status ≤ 2
Description

ECOG Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
able to perform oral rinsing
Description

Ability to perform oral rinsing

Data type

boolean

Alias
UMLS CUI [1,1]
C0442027
UMLS CUI [1,2]
C1882955
UMLS CUI [1,3]
C0085732
able to complete questionnaires by themselves or with assistance
Description

Ability to complete Questionnaires (by themselves or with assistance)

Data type

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0085732
UMLS CUI [2]
C1521721
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any previous systemic antineoplastic treatment within 4 weeks of initiation of current targeted anticancer therapy
Description

Previous Systemic antineoplastic tretment

Data type

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C1515119
UMLS CUI [1,3]
C0205156
current antineoplastic combination with cytotoxic chemotherapy
Description

Current combination of a cytotoxic chemotherapy to the antineoplastic treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0003392
UMLS CUI [1,3]
C0205420
physiologic condition that precludes the use of an oral rinse
Description

Condition that precludes oral rinsing

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0442027
UMLS CUI [1,3]
C1882955
UMLS CUI [1,4]
C1301624
hypersensitivity to caphosol ingredients
Description

Hypersensitivity to Caphosol Ingredients

Data type

boolean

Alias
UMLS CUI [1,1]
C1170120
UMLS CUI [1,2]
C1550600
UMLS CUI [1,3]
C0020517
use of palifermin, oral cryotherapy, low level laser therapy, topical oral steroids within 3 weeks of current targeted anticancer therapy
Description

Palifermin | Oral Cryotherapy | low level laser therapy | Topical Steroids

Data type

boolean

Alias
UMLS CUI [1]
C0677829
UMLS CUI [2]
C0279027
UMLS CUI [3]
C2064827
UMLS CUI [4,1]
C0010408
UMLS CUI [4,2]
C0442027
oral abnormalities defined as baseline oral assessment of nci-ctcae v4.0 grade > 0
Description

Oral abnormalities defines as base line oral assessment of NCI-CTCAE v4.0

Data type

boolean

Alias
UMLS CUI [1,1]
C0026633
UMLS CUI [1,2]
C3887242
current use of agents that are known to be strong inducers or inhibitors of cyp3a4 that can not be stopped
Description

Cytochrome P450 CYP3a4 Inhibitors, Irreversible | Cytochrome P450 CYP3a4 inducers, strong

Data type

boolean

Alias
UMLS CUI [1,1]
C3850053
UMLS CUI [1,2]
C0442821
UMLS CUI [1,3]
C1272690
UMLS CUI [2,1]
C3850041
UMLS CUI [2,2]
C0442821
UMLS CUI [2,3]
C1272690
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Similar models

Eligibility Oral Mucositis NCT01265810

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Age
Item
≥18 years of age
boolean
C0001779 (UMLS CUI [1])
Histological diagnosis of RCC | Histologicaldiagnosis of HCC | Histological diagnosis of GIST
Item
histological proof of rcc, hcc or gist
boolean
C0679557 (UMLS CUI [1,1])
C0007134 (UMLS CUI [1,2])
C0679557 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
C0679557 (UMLS CUI [3,1])
C0238198 (UMLS CUI [3,2])
Oral adverse events due to mono therapy with sunitinib, sorafenib, pazopanib, temsirolimus, or everolimus at study entry
Item
oral adverse events > grade 0 due to sunitinib, sorafenib, pazopanib, temsirolimus, or everolimus in mono therapy at study entry
boolean
C1176020 (UMLS CUI [1,1])
C4763675 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0442027 (UMLS CUI [1,4])
C1516119 (UMLS CUI [2,1])
C4763675 (UMLS CUI [2,2])
C0877248 (UMLS CUI [2,3])
C0442027 (UMLS CUI [2,4])
C2697888 (UMLS CUI [2,5])
C1831796 (UMLS CUI [3,1])
C4763675 (UMLS CUI [3,2])
C0877248 (UMLS CUI [3,3])
C0442027 (UMLS CUI [3,4])
C2697888 (UMLS CUI [3,5])
C1707080 (UMLS CUI [4,1])
C4763675 (UMLS CUI [4,2])
C0877248 (UMLS CUI [4,3])
C0442027 (UMLS CUI [4,4])
C2697888 (UMLS CUI [4,5])
C0541315 (UMLS CUI [5,1])
C4763675 (UMLS CUI [5,2])
C0877248 (UMLS CUI [5,3])
C0442027 (UMLS CUI [5,4])
C2697888 (UMLS CUI [5,5])
Written Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
ECOG Performance Status
Item
eastern co-operative oncology group (ecog) performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Ability to perform oral rinsing
Item
able to perform oral rinsing
boolean
C0442027 (UMLS CUI [1,1])
C1882955 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
Ability to complete Questionnaires (by themselves or with assistance)
Item
able to complete questionnaires by themselves or with assistance
boolean
C0034394 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C1521721 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Previous Systemic antineoplastic tretment
Item
any previous systemic antineoplastic treatment within 4 weeks of initiation of current targeted anticancer therapy
boolean
C0003392 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Current combination of a cytotoxic chemotherapy to the antineoplastic treatment
Item
current antineoplastic combination with cytotoxic chemotherapy
boolean
C0677881 (UMLS CUI [1,1])
C0003392 (UMLS CUI [1,2])
C0205420 (UMLS CUI [1,3])
Condition that precludes oral rinsing
Item
physiologic condition that precludes the use of an oral rinse
boolean
C0012634 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
C1882955 (UMLS CUI [1,3])
C1301624 (UMLS CUI [1,4])
Hypersensitivity to Caphosol Ingredients
Item
hypersensitivity to caphosol ingredients
boolean
C1170120 (UMLS CUI [1,1])
C1550600 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,3])
Palifermin | Oral Cryotherapy | low level laser therapy | Topical Steroids
Item
use of palifermin, oral cryotherapy, low level laser therapy, topical oral steroids within 3 weeks of current targeted anticancer therapy
boolean
C0677829 (UMLS CUI [1])
C0279027 (UMLS CUI [2])
C2064827 (UMLS CUI [3])
C0010408 (UMLS CUI [4,1])
C0442027 (UMLS CUI [4,2])
Oral abnormalities defines as base line oral assessment of NCI-CTCAE v4.0
Item
oral abnormalities defined as baseline oral assessment of nci-ctcae v4.0 grade > 0
boolean
C0026633 (UMLS CUI [1,1])
C3887242 (UMLS CUI [1,2])
Cytochrome P450 CYP3a4 Inhibitors, Irreversible | Cytochrome P450 CYP3a4 inducers, strong
Item
current use of agents that are known to be strong inducers or inhibitors of cyp3a4 that can not be stopped
boolean
C3850053 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C1272690 (UMLS CUI [1,3])
C3850041 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C1272690 (UMLS CUI [2,3])
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